***NEW*** PUBLIC HEALTH ADVISORY: FDA REQUIRES NEW BOXED WARNINGS FOR THE SMOKING CESSATION DRUGS CHANTIX AND ZYBAN

The FDA is notifying the public that the use of Chantix (varenicline) or Zyban (bupropion hydrochloride), two prescription medicines that are used as part of smoking cessation programs, has been associated with reports of changes in behavior such as hostility, agitation, depressed mood, and suicidal thoughts or actions.  The FDA is requiring the manufacturers of these products, including generic versions of Zyban (bupropion), to add a new Boxed Warning to the product labeling to alert healthcare professionals to this important new safety information.

People who are taking Chantix or Zyban and experience any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their healthcare professional right away.

Friends or family members who notice these changes in behavior in someone who is taking Chantix or Zyban for smoking cessation should tell the person their concerns and recommend that he or she stop taking the drug and call a healthcare professional right away.

CLICK HERE TO READ THE ENTIRE WARNING FROM THE FDA

Nine partner organizations, including CAFP, recently launched CS2day (Cessation of Smoking Today), an innovative continuing medical education (CME) initiative designed to improve public health by reducing the number of Americans who smoke. CS2day is a collaborative milestone, bringing together nine different organizations with expertise in education, measurement, evaluation and quality in order to meet the initiative’s goal of reaching 46,000 physicians and health care providers.

Read the press release.
Download a one-pager about CS2day. (.pdf)

The 9 partners that comprise the CME coalition for this initiative are the California Academy of Family Physicians, CME Enterprise, Healthcare Performance Consulting, Interstate Postgraduate Medical Association, Iowa Foundation for Medical Care, Physician’s Institute for Excellence in Medicine, Purdue University School of Pharmacy and Pharmaceutical Sciences, the University of Virginia School of Medicine and the University of Wisconsin School of Medicine and Public Health.

CAFP has three projects, plus financial management roles in the CS2day initiative.

Live Learning
CAFP has identified and assembled Curriculum Development Team:
Tom Bent, MD, Medical Director and Chief Operating Officer, Laguna Beach Community Clinic; Katherine Galluzzi, DO, CMD, FACOFP dist, Chair; Department of Geriatrics, Pennsylvania College of Osteopathic Medicine; and, Carol Havens, MD, Director of CME for Northern California Kaiser Permanente

After reviewing the CS2day project and associated materials, the team identified three key learning objectives:
1. Screen all patients for smoking status and evaluate all smokers for their readiness for quitting;
2. Design appropriate individual interventions for smoking cessation;
3. Commit to active follow-up with patients through their smoking cessation path.

The faculty decided to build a curriculum that will model the Five As for the attending learners. We weave a real patient case video into the learning experience to demonstrate each A. The PCPA motivational method will be covered, and audience response systems will be used throughout to both underscore key learnings, as well as to enhance learner interactivity. This curriculum is designed to be extremely practical and applied, and will provide useful information the learner can remember and use “Monday morning.”

Our live content debuted at our 60th Annual Scientific Assembly, April 26-27, 2008 in San Francisco, and will be presented through 2008-09 at five PriMed Conference and Exhibitions and 16 state AFP chapter meetings. Cynthia Kear is the staff lead on the live programming, assisted by Karen Brent and Jerri Davis.

Project Improvement
CAFP will run a 16-month learning collaboratory experience. We will have four AFP chapters and 15 practice teams involved. The collaboratory will incorporate face-to-face learning, virtual learning, conference calls, and a patient registry as a means of not only increasing quit rates, but assisting family physicians in implementing elements of practice re-design. The content will be driven by a Chronic Care Model Change Package, and learnings from our 3 years’ experience with diabetes collaboratories, such as our New Directions in Diabetes Care. We will use tools and clinical content developed by CEASE partners for our work. The IFMC patient registry will be vital to the project, as will work with the three other CS2day QI/PI projects.

CAFP’s Project Improvement Planning Panel had its first meeting in early March. The PI Project team lead is Alan Glaseroff, MD, nationally recognized in Quality Improvement work, and a CAFP member. Other members include Mike Zimmerman, MD, a New Directions in Diabetes Care standout, Tom Bent, MD, CAFP’s president-elect, and Jay Iinuma, MD, a member of the CAFP’s Committee on Professional Development.

Shelly Rodrigues is staff lead on this project, with Sandy Newman, MPH and Jane Cho coordinating the activities. The Ohio, West Virginia, Georgia and Texas AFP chapters have committed to participate in the project.

Financial Management
CAFP is responsible for receiving grant checks from Pfizer and disbursing grant payments to the Partners. In that role, CAFP also pays bills for conference calls, reimbursements for selected meetings, and is the signator on the CECity contract. CAFP maintains a separate account for the CS2day moneys, and will have records audited each year during the grant period. CAFP also serves as the financial link to Pfizer on grant matters, and will supply information for the quarterly reports to Pfizer. Shelly Rodrigues is staff lead on the financial management of this project, and in this capacity serves on the CS2day Executive Team.

For more information on the CS2day project and CAFP’s involvement, please contact Shelly Rodrigues, CAE at (415) 345-8668.